PATENT LICENSE AGREEMENT between PROTEIN DESIGN LABS, INC. and MEDIMMUNE, INC.
[ ]
= Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
between
PROTEIN
DESIGN LABS, INC.
and
MEDIMMUNE,
INC.
This
Agreement (“Agreement”), effective as of July 17, 1997 (“Effective Date”), is
made by and between PROTEIN DESIGN LABS, INC., a Delaware corporation having
offices at 0000 Xxxxxx Xxxxxx, Xxxxxxxx Xxxx, XX 00000, XXX (hereinafter “PDL”)
and MEDIMMUNE, INC., a Delaware corporation, having offices at 00 Xxxx Xxxxxxx
Xxxx Xxxx, Xxxxxxxxxxxx, XX 00000 (hereinafter
“MEDIMMUNE”).
RECITALS
A. MEDIMMUNE
desires to license certain patents owned or controlled by PDL related to a
humanized antibody directed against RSV (as defined below), which antibody has
involved significant development efforts undertaken by MEDIMMUNE (including
without limitation the antibody known as “MEDI-493”); and
B. PDL
is willing to license to MEDIMMUNE such rights under the terms and conditions of
this Agreement.
AGREEMENT
NOW
THEREFORE, in consideration of the mutual covenants herein contained and
intending to be legally bound, the parties agree as follows:
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1.
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DEFINITIONS
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All
references to Exhibits, Articles and Sections shall be references to Exhibits,
Articles and Sections of this Agreement. In addition, except as
otherwise expressly provided herein, the following terms in this Agreement shall
have the following meanings:
1.01 “Affiliate” means, with respect
to a party hereto, any corporate or other entity which, directly or indirectly,
controls, is controlled by, or is under common control with such party where
“control” means the ownership of not less than 50% of the voting shares of a
corporation, or decision-making authority as to an unincorporated
entity.
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1.02 “Combination Product(s)” shall
mean any product containing both a pharmaceutically active agent or ingredient
which constitutes a Licensed Product and one or more other pharmaceutically
active agents or ingredients which do not constitute Licensed
Products.
1.03 “Field” means the field of
human prophylaxis and therapy.
1.04 “Licensed Product(s)” shall
mean an Antibody for which MEDIMMUNE has undertaken significant development
efforts (e.g., conducted or sponsored a human clinical trial), which product is
an Antibody that binds to RSV (including without limitation, the MEDI-493
product of MEDIMMUNE or MEDIMMUNE’s sublicensees and any modifications or
improvements) whose development, importation, manufacture, use or sale would,
but for a license under this Agreement, infringe a Valid
Claim. “Antibody” as used in the preceding sentence shall include,
without limitation, monospecific and bispecific antibodies; less than
full-length antibody forms such as Fv, Fab, and F(ab’)(2); single-chain
antibodies; and antibody conjugates bound to a toxin, label or other
moiety.
1.05 “Net Sales” shall mean the
aggregate gross revenues, whether in cash or in kind, derived by or payable from
or on account of the sale of Licensed Products, less an allowance of Five
Percent (5%) to cover factors such as (a) credits or allowances, if any,
actually granted on account of price adjustments, recalls, rejection or return
of items previously sold, (b) excise and sales taxes, duties or other taxes
imposed on and paid with respect to such sales (excluding income or franchise
taxes of any kind) and (c) outer packing, freight and freight insurance
costs. If MEDIMMUNE or any of its Affiliates or sublicensees receive
non-cash consideration for any Licensed Product sold or otherwise transferred to
an independent third party not an Affiliate of the seller or transferor, the
fair market value of such non-cash consideration on the date of such
transfer as known to MEDIMMUNE, or as reasonably estimated by
MEDIMMUNE if unknown, shall be included in the definition of Net
Sales.
1.06 “PDL Patent Rights” means the
patents (as well as any foreign counterparts or patent applications thereto)
identified on Exhibit
A, including any addition, continuation, continuation-in-part or division
thereof or any substitute application therefor; any patent issued with respect
to such patent application, any reissue, extension or patent term extension of
any such patent, and any confirmation patent or registration patent or patent of
addition based on any such patent.
1.07 “Territory” means the
world.
1.08 “Valid Claim” means any claim
in any issued patent included in the PDL Patent Rights which has not been
disclaimed or held unenforceable or invalid by a governmental agency or court of
competent jurisdiction by a decision beyond right of review.
1.09 “Europe” means one or more the
following countries: U.K., France, Germany, Italy and
Spain.
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2.
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LICENSE
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2.01 License
Grant. Subject to the terms and conditions of this Agreement,
PDL hereby grants and MEDIMMUNE hereby accepts a nonexclusive license under the
PDL Patent Rights limited to the Field and Territory, including the right to
grant sublicenses (subject to Section 2.02), to make, import, have made, use or
sell Licensed Products.
2.02 Limitation on Sublicenses;
Notification of Grant of Sublicense. MEDIMMUNE shall have the
right to grant sublicenses of its rights under Section 2.01 only in connection
with the assignment or license by it of a Licensed Product to a third party and
only with respect to that Licensed Product. The right to grant
sublicenses under Section 2.01 shall be on terms and conditions which are
subject to and subordinate to the terms of this Agreement. Promptly
following execution of any sublicense hereunder, but in any event not less than
ten (10) days thereafter, MEDIMMUNE shall notify PDL of the identity of the
sublicensee and the scope of the sublicense.
2.03 Notification of Other Potential
Licensee. PDL shall use commercially reasonable efforts to
notify MEDIMMUNE in the event that a third party proposes to obtain a license
under the PDL Patent Rights in the Field. MEDIMMUNE shall have a
period of ten (10) business days from notification to propose terms for an
amendment to this Agreement for an exclusive license in the Field and
Territory. PDL agrees to reasonably consider any proposal to enter
into an amendment to this Agreement for an exclusive license proposed by
MEDIMMUNE, but neither party shall have any obligation to enter into such
amendment.
2.04 Most Favored
Licensee. PDL has not granted and agrees not to grant a
license under the Queen Patent (as defined in Exhibit A) to a third party, other
than a PDL Affiliate, for use in the Field with a royalty rate less than
[ ] of net sales of licensed products unless MEDIMMUNE is
provided the same royalty rate as such third party, provided that if the royalty
rate in said third party license is less than [ ] and the
agreement with that third party involves other terms conveying any economic
benefit to PDL, MEDIMMUNE shall be provided the same royalty rate as such third
party if MEDIMMUNE provides economic benefit to PDL of equal value (with full
credit with respect to such economic benefit to MedImmune for licensing fees,
milestones and maintenance fees previously paid under this
Agreement). Notwithstanding the foregoing, PDL will be able to grant
one license under the Queen Patent under more favorable terms in the Field
without the royalty reduction and credit to MedImmune provided herein, provided
that such license is not for use of an antibody binding to RSV. PDL shall
promptly notify MEDIMMUNE in the event that PDL proposes to grant such a license
under the Queen Patent to a third party with a royalty rate less than
[ ]. The parties agree to execute such documents as
may be reasonably necessary to carry out the purposes of this Section
2.04.
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3.
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MILESTONE
PAYMENTS; ROYALTIES, REPORTS
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3.01 Payments. In
consideration for the license granted by PDL under Article 2 of this Agreement
MEDIMMUNE shall pay the amounts set forth in this Section 3.01.
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(a) Initial
Payment. Unless this Agreement is terminated as provided in
Section 7.02(a), not later than September 1, 1997 MEDIMMUNE shall pay to PDL a
nonrefundable signing and licensing fee in the sum of
[ ].
(b) Milestone
Payments.
i. Filing of Biologics License
Application(s). Within thirty (30) days following the
submission of a biologics license application (or foreign counterpart thereto)
to regulatory authorities with respect to a Licensed Product in any country in
the Territory, MEDIMMUNE shall pay to PDL a one time nonrefundable sum of
[ ].
ii. Approval to Market in the
U.S. Within thirty (30) days following the initial approval to
market a Licensed Product in the U.S., MEDIMMUNE shall pay to PDL the
nonrefundable sum of [ ].
iii. Approval to Market in
Europe. Within thirty (30) days following the initial approval
to market a Licensed Product in any country in Europe, MEDIMMUNE shall pay to
PDL the nonrefundable sum of [ ].
iv. First Sale in the
U.S. Within thirty (30) days following the initial sale of a
Licensed Product that, but for the licenses granted to MEDIMMUNE under this
Agreement would infringe a Valid Claim in the U.S., MEDIMMUNE shall pay to PDL
the nonrefundable sum of [ ].
v. First Sale in
Europe. Within thirty (30) days following the initial sale of
a Licensed Product that, but for the licenses granted to MEDIMMUNE under this
Agreement would infringe a Valid Claim in any country in Europe, MEDIMMUNE shall
pay to PDL the nonrefundable sum of [ ].
Each
milestone set forth in this Section 3.01 shall be deemed achieved and the
corresponding milestone payment due upon the achievement of the milestone,
whether by MEDIMMUNE, its Affiliates or sublicensees. Any payment
made by MEDIMMUNE for the achievement of any milestone herein shall be paid by
MEDIMMUNE only once.
3.02 Annual Maintenance
Fee. In further consideration of the license granted under
Article 2, not later than June 30, 2000 and not later than May 31 each year
thereafter, MEDIMMUNE shall pay PDL a nonrefundable annual maintenance fee in
the amount of [ ].
3.03 Royalties to PDL; Credits Against
Royalties.
(a) In
further consideration of the rights and licenses granted under Article 2,
MEDIMMUNE shall pay to PDL a royalty of [ ] of the Net Sales of
all Licensed Products sold by MEDIMMUNE or its Affiliates or sublicensees to
non-Affiliated third parties in each country in the Territory until the last
date on which there is a Valid Claim that, but for the licenses granted to
MEDIMMUNE under this Agreement, would be infringed by the making, importing,
using, having made or sale of that Licensed Product in such country in the
Territory or by the manufacture of Licensed Product in the country of
manufacture.
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(b) [ ]
3.04 Sales Among
Affiliates. Sales between and among MEDIMMUNE, its
sublicensees and its Affiliates of Licensed Products which are subsequently
resold or to be resold by such sublicensees or Affiliates shall not be subject
to royalty, but in such cases royalties shall accrue and be calculated on any
subsequent sale of such Licensed Products to a non-affiliated third
party.
3.05 Combination
Products. Net Sales in a particular country in the Territory,
in the case of Combination Products for which the pharmaceutically active agent
or ingredient constituting a Licensed Product and each of the other
pharmaceutically active agents or ingredients not constituting Licensed Products
have established market prices in that country in the Territory when sold
separately, shall be determined by multiplying the Net Sales for each such
Combination Product by a fraction, the numerator of which shall be the
established market price for the Licensed Product(s) contained in the
Combination Product and the denominator of which shall be the sum of the
established market prices for the Licensed Product(s) plus the established
market prices for the other pharmaceutically active agents or ingredients
contained in the Combination Product. When such separate market
prices are not established in that country in the Territory, then the parties
shall negotiate in good faith to determine a fair and equitable method of
calculating Net Sales in that country for the Combination Product in
question.
3.06 Withholding.
(a) Payments. MEDIMMUNE
shall pay all amounts payable to PDL under Section 3.01 and Section 3.02 from a
U.S. bank account. Any deductions for any taxes or other withholding
that may be applicable to the payments to PDL under Sections 3.01 and 3.02 shall
be promptly paid by MEDIMMUNE to the appropriate governmental authority and
MEDIMMUNE shall provide proof of payment to PDL.
(b) Royalty
Payments. MEDIMMUNE may withhold from royalties due to PDL
amounts for payment of any withholding tax that MEDIMMUNE has paid to any taxing
authority with respect to royalties due on account of the sale or manufacture of
Licensed Products in the Territory. MEDIMMUNE agrees to reasonably
cooperate with PDL in obtaining a foreign tax credit in the U.S. with respect to
royalties due to PDL on the sale or manufacture of Licensed
Products.
3.07 Currency
Conversion. All amounts payable to PDL under this Agreement
shall be payable in U.S. Dollars by wire transfer to-a bank account designated
by PDL. In the case of royalties on Net Sales, all amounts payable
shall first be calculated in the currency of sale and then converted into U.S.
Dollars using the average of the daily exchange rates for such currency quoted
by Citibank, N.A. for each of the last fifteen (15) banking days of each
calendar quarter.
3.08 Royalty Reports.
(a) Current
Reports. MEDIMMUNE agrees to make written reports and royalty
payments to PDL within forty-five (45) days after the close of each calendar
quarter during the term of this Agreement, beginning with the calendar quarter
in which the date of first commercial sale occurs. These reports
shall show for the calendar quarter in question Net Sales by MEDIMMUNE, its
Affiliates and sublicensees of the Licensed Products in the Territory on a
country-by-country basis, details of the quantities of Licensed Products sold in
each country and the country of manufacture if different, and the royalty due to
PDL thereon pursuant to Article 2. Concurrently with the making of
each such report, MEDIMMUNE shall make any payment due to PDL of royalties for
the period covered by such report.
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(b) Termination
Report. For each Licensed Product, MEDIMMUNE also agrees to
make a written report to PDL within ninety (90) days after the date on which
MEDIMMUNE, its Affiliates or sublicensees last sell that Licensed Product in the
Territory stating in such report the same information required by quarterly
reports for all such Licensed Products made, sold or otherwise disposed of which
were not previously reported to PDL.
3.09 Inspection. MEDIMMUNE
agrees to keep clear, accurate and complete records for a period of at least
three (3) years (or such longer period as may correspond to MEDIMMUNE’s internal
records retention policy) for each reporting period in which Net Sales occur
showing the manufacturing, sales, use and other disposition of Licensed Products
in the Territory in sufficient detail to enable the royalties payable hereunder
to be determined, and further agrees to permit its books and records to be
examined by an independent accounting firm selected by PDL and reasonably
satisfactory to MEDIMMUNE, from time-to-time to the extent necessary, during
normal business hours and upon reasonable notice, but not more than once a
year. Such examination is to be made at the expense of PDL, except in
the event that the results of the audit reveal that MEDIMMUNE underpaid PDL by
five percent (5%) or more, then the audit fees shall be paid by
MEDIMMUNE. Any such discrepancies will be promptly corrected by a
payment or refund, as appropriate.
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4.
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PATENT
UPDATE
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4.01 Updates. Upon the
written request of MEDIMMUNE (which request shall not be made more than once per
calendar year), PDL agrees to provide a written update of the information
relating to the PDL Patent Rights as set forth on Exhibit
A.
4.02 Defense of PDL Patent
Rights. With respect to the PDL Patent Rights licensed under
this Agreement, PDL at its sole cost and expense agrees to take all steps and
proceedings and to undertake such other acts as PDL may, in its sole discretion,
deem necessary or advisable to restrain any infringement or improper or unlawful
use of the PDL Patent Rights in the Field and Territory. MEDIMMUNE
shall permit PDL to have the sole right to take such steps, conduct any such
proceedings or undertake any such actions to restrain any infringement or
improper or unlawful use of the PDL Patent Rights in the Territory, whether or
not MEDIMMUNE is a party to such steps, proceedings or actions. Any
Moines recovered from alleged infringers shall be retained by PDL.
4.03 Notification. MEDIMMUNE
shall promptly notify PDL in writing of any actual or suspected infringement of
any PDL Patent Right, which notification shall specify in reasonable detail the
nature of such actual or suspected infringement. If, in MEDIMMUNE’s
reasonable opinion, PDL has not undertaken action reasonably designed to
restrain any infringement or improper or unlawful use of the PDL Patent Rights
with respect to an Antibody directed against RSV by such third party in the
particular country and MEDIMMUNE’s market share of the indications for which
Licensed Products are sold in that country is reduced by [ ] or
more as a result of the infringing or unlawful use of PDL Patent Rights with
respect to an Antibody directed against RSV, then MEDIMMUNE shall be entitled to
reduce the royalties payable on Net Sales of Licensed Products in that country
as follows: (a) by [ ] if MEDIMMUNE’s market share is reduced
by [ ] up to [ ], and (b) by
[ ] if MEDIMMUNE’s market share is reduced by
[ ] or more; provided that the royalty rate on Net Sales of
Licensed Products in that country shall revert to the applicable royalty rate
under Section 3.03 at such time as the infringement is abated.
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5.
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REPRESENTATIONS
AND WARRANTIES; INDEMNIFICATION
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5.01 Valid
Agreement. Each party represents and warrants to the other
that it knows of no legal reason to prevent it from entering into this Agreement
and that the signatory hereto is duly authorized to execute and deliver this
Agreement. In addition, PDL represents and warrants that it is the
owner of the PDL Patent Rights.
5.02 No Warranty of Validity,
Non-Infringement. Nothing in this Agreement shall be construed
as (a) a warranty or representation by PDL as to the validity or scope of any
PDL Patent Rights; or (b) a warranty or representation that any Licensed Product
made, used, sold or otherwise disposed of under the license granted in this
Agreement is or will be free from infringement of patents, copyrights,
trademarks, trade secrets or other rights of third parties.
5.03 No Other
Warranties. EXCEPT AS SPECIFICALLY SET FORTH IN ARTICLE 5, PDL
MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
WITH RESPECT TO ANY CELL LINES, ANTIBODIES, LICENSED PRODUCTS DEVELOPED BY
MEDIMMUNE UNDER THE LICENSE SET FORTH IN THIS AGREEMENT AND PDL FURTHER MAKES NO
EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, OR THAT THE USE OF ANY CELL LINES, ANTIBODIES, LICENSED PRODUCTS OR
OTHER MATERIALS DEVELOPED BY MEDIMMUNE UNDER THE LICENSE SET FORTH IN THIS
AGREEMENT WILL NOT INFRINGE ANY THIRD PARTY RIGHTS.
5.04 Indemnification. MEDIMMUNE
shall at all times, during the term of this Agreement and thereafter, defend,
indemnify and hold harmless PDL and its Affiliates, sublicensees, directors,
officers, agents and employees from any third party claim, proceeding, loss,
expense, and liability of any kind whatsoever (including but not limited to
those resulting from death, personal injury, illness or property damage and
including legal expenses and reasonable attorneys’ fees) arising out of or
resulting from the development, manufacture, holding, use, testing,
advertisement, sale or other disposition by MEDIMMUNE, its Affiliates or
sublicensees, or any distributor, customer or representative of MEDIMMUNE or any
one in privity therewith, of any Licensed Product. PDL shall give
MEDIMMUNE prompt notice of any such claim, proceeding or action and MEDIMMUNE
shall control the defense, settlement or compromise of any such claim,
proceeding or action; provided that the control granted to MEDIMMUNE hereunder
shall not include any right to grant licenses or sublicenses under the PDL
Patent Rights without the prior written consent of PDL, which consent may be
withheld in PDL’s sole discretion.
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6.
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CONFIDENTIALITY
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6.01 Confidentiality. PDL
and MEDIMMUNE acknowledge that in the course of negotiations and furtherance of
the interests of the parties hereunder that it (“Recipient”) may receive
confidential information of the other party
(“Provider”). “Confidential Information” means any and all data and
information which (a) has been reduced to tangible form and marked clearly and
conspicuously with a legend identifying its confidential or proprietary nature;
or (b) with respect to any oral presentation or communication, is designated as
confidential immediately before, during, or within a reasonable time after the
oral presentation or communication and such designation is subsequently
confirmed in writing; or (c) is otherwise characterized by Provider as
confidential information.
6.02 Limitations on Use; Information Not
Considered Confidential. Except as expressly provided in
Section 8.03(a), each party shall keep confidential, and shall not use the
Confidential Information of the other party for any purpose other than the
development and commercial exploitation of Licensed Products in the Territory,
during the term of this Agreement and for five (5) years after termination
hereof, all Confidential Information heretofore and hereafter supplied by the
other, provided however, that the foregoing obligation of confidentiality shall
not apply to the extent that any Confidential Information (a) is
already known to the recipient at the time of disclosure or is developed by
recipient thereafter in the course of work entirely independent of any
disclosure by the other party; (b) is publicly known prior to or
becomes publicly known after disclosure other than through acts or omissions of
the recipient; (c) is disclosed in good faith to recipient by a third
party under a reasonable claim of right, or (d) is required to be disclosed
pursuant to an order of a court of law or governmental agency; provided that the
disclosing party shall advise the other party promptly of any such disclosure
requirement in order to permit such other party to undertake efforts to restrict
or limit the required disclosure.
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7.
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TERM
AND TERMINATION
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7.01 Term. Unless
earlier terminated as provided in this Article 7, this Agreement shall come into
force on the date first set forth above and shall continue until the expiration
of the obligation to pay royalties to PDL in accordance with Article 3
above. Thereafter, this Agreement shall terminate and all licenses or
sublicenses granted hereunder shall become fully paid-up, irrevocable
licenses.
7.02 Termination.
(a) This
Agreement may be terminated by MEDIMMUNE (I) immediately upon written notice
that it is terminating further development of MEDI-493 (or any successor
thereto); or (II) for convenience on thirty (30) days prior written
notice.
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(b) If either
party shall at any time default in the payment of any royalty, or the making of
any report hereunder, or shall commit any material breach of any covenant or
agreement herein contained or shall make any false report, and shall fail to
have initiated and actively pursued remedy of any such default or breach within
(I) in the case of default in payment, ten (10) days, and (II) in all other
cases of default or breach, thirty (30) days after receipt of written notice
thereof by the other party, that other party may, at its option, cancel this
Agreement and revoke any rights and licenses herein granted and directly
affected by the default or breach by notice in writing to such effect, but such
act shall not prejudice the right of the party giving notice to recover any
royalty or other sums due at the time of such cancellation, it being understood,
however, that if within the specified cure period after receipt of any such
notice the receiving party shall have initiated and actively pursued remedy of
its default, then the rights and licenses herein granted shall remain in force
as if no breach or default had occurred on the part of the receiving party,
unless such breach or default is not in fact remedied within a reasonable period
of time.
(c) This
Agreement may be terminated by either party upon the occurrence of any of the
following which is not stayed or vacated within ninety (90) days of such
occurrence: (i) petition in bankruptcy filed by or against the other
party; (ii) adjudication of the other party as bankrupt or insolvent; (iii)
appointment of a liquidator, receiver or trustee for all or a substantial part
of the other party’s property; or (iv) an assignment for the benefit of
creditors of the other party.
7.03 No Waiver. The
right of either party to terminate this Agreement as provided herein shall not
be affected in any way by its waiver of, or failure to take action with respect
to, any previous failure to perform hereunder.
7.04 Survival. Termination
for any reason hereunder shall not affect any accrued rights or obligations of
the parties arising in any manner under this Agreement as of the date of
termination. In any event, the confidentiality and indemnity
obligations and any accrued payment obligations under Articles 3, 5 and 6 shall
survive any termination of this Agreement.
7.05 Direct License. In
the event that this Agreement terminates, any sublicense granted under the terms
of Section 2.02 hereunder shall, upon the written request of the sublicensee,
become a direct license between PDL and that sublicensee so long as the (a)
sublicense does not impose obligations on PDL beyond those set forth in this
Agreement, and (b) sublicensee is not in breach of its sublicense agreement or,
mutatis mutandis, the terms of this Agreement.
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8.
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MISCELLANEOUS
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8.01 Force
Majeure. Neither party shall be responsible to the other for
failure or delay in performing any of its obligations under this Agreement or
for other non-performance hereof provided that such delay or non-performance is
occasioned by a cause beyond the reasonable control and without fault or
negligence of such party, including, but not limited to earthquake, fire, flood,
explosion, discontinuity in the supply of power, court order or governmental
interference, act of God, strike or other labor trouble and provided that such
party will inform the other party as soon as is reasonably practicable and that
it will entirely perform its obligations immediately after the relevant cause
has ceased its effect.
8.02 Validity. Should
one or several provisions of the Agreement be or become invalid, then the
parties hereto shall substitute such invalid provisions by valid ones, which in
their economic effect come so close to the invalid provisions that it can be
reasonably assumed that the parties would have contracted this Agreement with
those new provisions. In the event that such provisions cannot be
determined or are legally impermissible, the invalidity of one or several
provisions of the Agreement shall not affect the validity of the Agreement as a
whole, unless the invalid provisions are of such essential importance for this
Agreement that it is to be reasonably assumed that the parties would not have
contracted this Agreement without the invalid provisions.
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8.03 [ ]
8.04 Notices. Any notice
or report required or permitted to be given under this Agreement shall be in
writing and shall be sent by expedited delivery or telecopied and confirmed by
mailing, as follows and shall be effective three (3) days after such
delivery:
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If
to PDL:
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Protein
Design Labs, Inc.
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0000
Xxxxxx Xxxxxx
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Xx.
Xxxx, Xxxxxxxxxx 00000 XXX
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Attention: Chief
Executive Officer
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Copy
to:
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Protein
Design Labs, Inc.
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0000
Xxxxxx Xxxxxx
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Xx.
Xxxx, Xxxxxxxxxx 00000 XXX
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Attention: General
Counsel
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If
to MEDIMMUNE:
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MedImmune,
Inc.
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00
Xxxx Xxxxxxx Xxxx Xxxx
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Xxxxxxxxxxxx,
XX 00000
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Attention:
Chief Executive Officer
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Copy
to:
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Xxxxxx
X. Xxxxxxx, Esq.
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Carella,
Byrne, Bain, Gilfillan, Xxxxxx, Xxxxxxx &
Xxxxxxx
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0
Xxxxxx Xxxx Xxxx
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Xxxxxxxx,
XX 00000
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8.05 Governing Law. The
validity, performance, construction, and effect of this Agreement shall be
governed by the laws of the State of California without regard to choice of law
principles.
8.06 Entire
Agreement. This Agreement constitutes the entire Agreement
between the parties hereto with respect to the within subject matter and
supersedes all previous Agreements, whether written or oral. This
Agreement shall not be changed or modified orally, but only by an instrument in
writing signed by both parties.
8.07 Assignment. The
rights of either party under this Agreement may not be assigned, and the duties
of either party under this Agreement may not be delegated, without the prior
written consent of the other party, which consent shall not be unreasonably
withheld; provided however, that either party may assign this Agreement without
prior written consent to a party which acquires all or substantially all of the
assignor’s business, whether by merger, sale of assets or
otherwise.
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8.08 Publicity. PDL may
issue a press release identifying the identity of MEDIMMUNE, the parties’ entry
into this Agreement, with the content of such release to be approved in advance
by MEDIMMUNE, which approval shall not be unreasonably
withheld. Except as required by law, neither party shall publicly
disclose the terms and conditions of this Agreement unless expressly authorized
to do so by the other party, which authorization shall not be unreasonably
withheld. In the event that it is determined that a disclosure shall
be made by either or both of the parties hereunder, then the parties will work
together to develop a mutually acceptable disclosure. MEDIMMUNE
agrees to provide PDL with press releases or other information regarding the
development status of the Licensed Products hereunder; provided that PDL shall
have no obligation to publicly update the status of any Licensed
Product.
8.09 Headings. The
captions used herein are inserted for convenience of reference only and shall
not be construed to create obligations, benefits, or limitations.
8.10 Export. Each party
acknowledges that the laws and regulations of the United States restrict the
export and re-export of commodities and technical data of United States
origin. Each party agrees that it will not export or re-export
restricted commodities or the technical data of the other party in any form
without the appropriate United States and foreign government
licenses.
8.11 Counterparts. This
Agreement may be executed in any number of counterparts, each of which shall be
deemed to be an original, and such counterparts together shall constitute one
agreement.
IN
WITNESS WHEREOF, the parties hereto have duly executed this Agreement as of the
date first above written.
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PDL:
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MEDIMMUNE:
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PROTEIN
DESIGN LABS, INC.
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MEDIMMUNE,
INC.
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By: /s/ Xxx
Xxxx
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By: /s/ Xxxxx X.
Xxxx
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Title: President
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Title: President and Chief
Operating
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11
EXHIBIT
A
PDL
Patent Rights
The
following are patents (the “Queen Patent”) issued in certain countries in the
world as of the Effective Date and licensed under the Agreement. The
Queen Patent shall expressly include any patent applications and foreign
counterparts thereto filed by PDL before or during the term of this
Agreement.
1. European
Patent number 0000000X0, Queen, “Humanized Immunoglobulins and their production
and use”.
2. U.S.
patent application number 5,530,101, Queen, “Improved Humanized
Immunoglobulins”.
3. U.S.
patent continuations, continuations-in-part, and divisional applications numbers
[ ]of issued U.S. patent number 5,530,101, Queen, “Improved
Humanized Immunoglobulins”.
4. Japan
patent application number [ ], Queen, “Improved Humanized
Immunoglobulins”
12
